EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment

RCT Comparing the Efficacies of Endoscopic Band Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding in Patients With Previous Endoscopic Variceal Treatment

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00966082

Enrollment

180

Registered

2009-08-26

Start date

2008-08-31

Completion date

2021-07-31

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Variceal Bleeding

Keywords

Cirrhosis, Esophagus Disorders, Varicose Veins

Brief summary

This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Detailed description

Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.

Interventions

PROCEDUREendoscopic band ligation

Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval

PROCEDUREendoscopic band ligation+Propranolol

Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Liver cirrhosis * Age between 18 and 70 years * Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion criteria

* Gastric variceal bleeding * Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min * Portal vein thrombosis * Prominent hepatic encephalopathy * Coexisting untreated malignancy * Severe cerebrovascular or cardiovascular disease, renal failure * No previous history of endoscopic, radiologic, or surgical treatment for varices or ascites * Contraindication to beta-blocker * Pregnancy * Refusal to give consent to participate in the trial

Design outcomes

Primary

Measure	Time frame	Description
Rebleeding from esophageal varices	2 years	Rebleeding from esophageal varices

Secondary

Measure	Time frame	Description
Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events	2 years	Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events

Countries

South Korea

Contacts

Primary ContactSoon Ho Um, Prof

umsh@korea.ac.kr82-2-920-5019

Backup ContactYeon Seok Seo, MD

drseo@korea.ac.kr82-2-920-6608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026